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To: Jim Spitz who wrote (30763)	7/12/2001 9:14:15 AM
From: Jim Spitz	Respond to of 37746

New-feature pacemaker approved for St. Jude Terry Fiedler Star Tribune Thursday, July 12, 2001 Little Canada-based St. Jude Medical on Wednesday became the first company to get Food and Drug Administration approval for a device to treat the widespread heart condition atrial fibrillation. The approval for St. Jude's Integrity AFx pacemaker came without an FDA panel meeting and about five months ahead of expectations. Analysts said the product should solidify St. Jude's spot as the No. 2 pacemaker company in the world. At the end of 2000, Fridley-based Medtronic Inc., the perennial pacemaker leader, had 51 percent of the worldwide market. St. Jude had 22 percent and Indianapolis-based Guidant Corp., which has its cardiac rhythm management group and about 2,200 employees in Arden Hills, was third with 19 percent. "The market rewards innovators. They're first to market with a brand-new feature, beating Guidant and Medtronic, and it's the smallest of three [companies]," said U.S. Bancorp Piper Jaffray analyst Thomas Gunderson. St. Jude had $1.21 billion in sales for the year ended March 31. Gunderson added that company probably would be able to charge more for its pacemakers as a result. "It's the opening gambit in atrial fibrillation," said Lehman Bros. analyst David Gruber, who noted that 30 to 50 percent of patients with pacemakers have or will develop atrial fibrillation. St. Jude stock was up 3 cents a share Wednesday, to $62.32, on a day when many other health-care issues were down. Atrial fibrillation is characterized by rapid, uncoordinated contractions of the atria, the upper chambers of the heart. The condition keeps the heart from pumping blood efficiently and can lead to a stroke. About 2 million Americans have atrial fibrillation and its prevalence increases with age. Four percent of U.S. men and women older than 60 and 10 percent of those older than 80 have atrial fibrillation. Until recently, the condition was treated primarily with drugs. St. Jude's Integrity AFx pacemaker monitors and uses electrical current to stimulate hearts that are beating too slowly, but also monitors atrial activity and delivers current to suppress atrial fibrillation. Many people implanted with St. Jude pacemakers in the past year already have the atrial fibrillation feature built into the product. The feature can be activated by their doctors in a non-invasive procedure. -- Terry Fiedler is at tfiedler@startribune.com . © Copyright 2001 Star Tribune. All rights reserved.